Ibandronic Acid Actavis 50mg Film-Coated Tablets
Package leaflet: Information for the patient
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• The full name of this medicine is Ibandronic Acid 50mg Film-coated Tablets but within the leaflet it will be referred to as Ibandronic acid tablets.
What is in this leaflet:
J What Ibandronic acid tablets are and what they are used for
^ What you need to know before you take ^ How to take ^1 Possible side effects Jl How to store
^1 Contents of the pack and other information
j What Ibandronic acid tablets are and what they are used for
Ibandronic acid tablets contain the active substance ibandronic acid. This belongs to a group of medicines called bisphosphonates.
Ibandronic acid tablets are indicated in adults and prescribed to you if you have breast cancer that has spread to your bones (called bone "metastases”).
It helps to prevent your bones from breaking (fractures).
It also helps to prevent other bone problems that may need surgery or radiotherapy.
Ibandronic acid tablets work by reducing the amount of calcium that is lost from your bones. This helps to stop your bones from getting weaker.
^ What you need to know before you take
Do not take Ibandronic acid tablets if you:
• are allergic to ibandronic acid or any of the other ingredients of this medicine that are listed in section 6
• have problems with your food pipe/gullet
(oesophagus) such as narrowing or difficulty swallowing
• cannot stand or sit upright for at least one hour
(60 minutes) at a time.
• Have or ever had low calcium in your blood.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Ibandronic acid tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Ibandronic acid tablets if you:
• are allergic to any other bisphosphonates
• have any swallowing or digestion problems
• have high or low blood levels of vitamin D or any other minerals
• have kidney problems
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• have a galactose intolerance, the Lapp lactase
deficiency or have problems with glucose galactose absorption
• are having dental treatment or surgery or know that you need some in the future, tell your dentist that you are being treated with Ibandronic acid for cancer.
Irritation, inflammation or ulceration of the gullet/ food pipe (oesophagus) often with symptoms of severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or vomiting may occur, especially if you do not drink a full glass of water and/or if you lie down within an hour of taking Ibandronic acid 50 mg. If you develop these symptoms, stop taking Ibandronic acid 50 mg and tell your doctor straight away (see sections 3 and 4).
Children and adolescents
Ibandronic acid tablets should not be used in children and adolescents below the age of 18 years.
Other medicines and Ibandronic acid
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Ibandronic acid tablets can affect the way some other medicines work.
Also some other medicines can affect the way Ibandronic acid tablets work.
In particular, tell your doctor or pharmacist if you
are taking any of the following medicines:
• supplements containing calcium, magnesium, iron or aluminium
• acetylsalicylic acid and non-steroidal antiinflammatory drugs called "NSAIDs” such as ibuprofen or naproxen.
This is because NSAIDs and Ibandronic acid tablets can both irritate your stomach and gut
• a type of antibiotic injection called "aminoglycoside” such as gentamicin. This is because aminoglycosides and Ibandronic acid tablets can both lower the amount of calcium in your blood.
Taking medicines that reduce stomach acid such as cimetidine and ranitidine, may slightly increase the effects of Ibandronic acid tablets.
Ibandronic acid tablets with food and drink
Do not take Ibandronic acid with food or any other drinks except water as Ibandronic acid is less effective if it is taken with food or drink (see section 3).
Take Ibandronic acid at least 6 hours after you had last had anything to eat, drink or any other medicines or supplements (e.g. products containing calcium (milk), aluminum, magnesium and iron) except water. After taking your tablet, wait at least 30 minutes. Then you can have your food and drink and take any medicines or supplements (see section 3).
Pregnancy and breast feeding
Do not take Ibandronic acid tablets if you are pregnant, planning to get pregnant or if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicines.
Driving and using machines
You can drive and use machines as it's expected that Ibandronic acid 50 mg has no or negligible effect on your ability to drive and use machines. Talk to your doctor first if you want to drive, use machinery or tools.
Ibandronic acid tablets contain lactose
Ibandronic acid tablets contain a type of sugar called lactose. If you have been told by your doctor that you cannot tolerate or digest some sugars (e.g. if you have a galactose intolerance, the Lapp lactase deficiency or have problems with glucose-galactose absorption), talk to your doctor before taking this medicine.
Continued over page
How to take
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Take your tablet at least 6 hours after you had last had anything to eat, drink or any other medicines or supplements except water. Water with a high concentration of calcium should not be used. If there is concern regarding potentially high levels of calcium in the tap water (hard water), it is advised to use bottled water with a low mineral content.
Your doctor may do regular blood tests while you are taking Ibandronic acid tablets. This is to check that you are being given the right amount of medicine.
Taking this medicine
It is important that you take Ibandronic acid tablets at the right time and in the right way. This is because it can cause irritation, inflammation or ulcers in your food pipe/gullet (oesophagus).
You can help stop this happening by doing the following:
• Take your tablet as soon as you get up for the day before having your first food, drink, any medicine or supplements.
• Take your tablet with a full glass of plain water only (about 200 ml). Do not take your tablet with any drink other than plain water.
• Swallow the tablet whole. Do not chew, suck
or crush the tablet. Do not let the tablet dissolve in your mouth.
• After taking your tablet, wait at least 30 minutes. Then you can have your first food and drink, and take any medicines or supplements.
• Stay upright (sitting or standing) while taking your tablet and for the next hour (60 minutes). Otherwise, some of the medicine could leak back into your food pipe/gullet (oesophagus).
How much to take
The usual dose of Ibandronic acid is one tablet each day. If you have moderate kidney problems, your doctor may reduce your dose to one tablet every other day. If you have severe kidney problems, your doctor may reduce your dose to one tablet each week.
If you take more Ibandronic acid tablets than you should
If you take too many tablets talk to a doctor or go to hospital straight away. Drink a full glass of milk before you go. Do not make yourself sick. Do not lie down.
If you forget to take Ibandronic acid tablets
Do not take a double dose to make up for a forgotten dose. If you are taking a tablet each day, skip the missed dose completely. Then carry on as usual the next day. If you are taking a tablet every other day or once a week, ask your doctor or pharmacist for advice.
If you stop taking Ibandronic acid tablets
Keep taking Ibandronic acid tablets for as long as your doctor tells you. This is because the medicine will only work if it is taken all the time.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects although not everybody gets them.
Talk to a nurse or a doctor straight away if you notice any of the following serious side effects -you may need urgent medical treatment:
Common (may affect up to 1 in 10 people):
• feeling sick, heartburn and discomfort in swallowing (inflammation of your gullet/food pipe)
Uncommon (may affect less than 1 in 100 people):
• severe stomach pain. This could be a sign of an ulcer of the first section of the bowel (duodenum) that is bleeding, or that your stomach is inflamed (gastritis)
Rare (may affect up to 1 in 1,000 people)
• persistent eye pain and inflammation
• new pain, weakness or discomfort in your thigh, hip or groin. You may have early signs of a possible unusual fracture of the thigh bone
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Very rare (may affect up to 1 in 10,000 people)
• pain or sore in your mouth or jaw. You may have early signs of severe jaw problems (necrosis (dead bone tissue) in the jaw bone)
• itching, swelling of your face, lips, tongue and throat, with difficulty breathing. You may be having a serious, potentially life threatening allergic reaction
• severe adverse skin reactions
• talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear.
Not known (frequency cannot be estimated from the available data)
• asthma attack
Other possible side effects
Common (may affect up to 1 in 10 people)
• feeling tired
• stomach pain, indigestion
• low calcium levels in your blood.
Uncommon (may affect less than 1 in 100 people)
• chest pain
• itching or tingling skin (paraesthesia)
• flu-like symptoms, feeling generally unwell or in pain
• dry mouth, strange taste in your mouth or difficulty swallowing
• anaemia (bloodlessness)
• high levels of urea or high levels of parathyroid hormone in your blood.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
T| How to store
Keep out of the sight and reach of children.
Do not use Ibandronic acid tablets after the expiry date which is stated on the blister and carton after 'EXP'. The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
« Contents of the pack and other information
What Ibandronic acid 50mg tablets contain
The active substance is 56.25mg of ibandronic acid, monosodium salt, monohydrate, equivalent to 50mg of ibandronic acid.
The other ingredients are lactose monohydrate, crospovidone (E1202), microcrystalline cellulose (E460), colloidal anhydrous silica (E551), sodium stearyl fumarate (tablet core); polyvinyl alcohol, macrogol/PEG 3350, talc (E553b) and titanium dioxide (E171) (tablet coating).
What Ibandronic acid 50mg tablets look like and contents of the pack
Ibandronic acid tablets are white to off-white, oblong tablets inscripted with "I9BE” on one side and "50” on the other side.
They are available in blister packs of 28
Marketing Authorisation Holder Actavis Group PTC ehf.
Reykjavikurvegur 76-78,
220 Hafnarfjordur Iceland
Manufacturer
Synthon Hispania SL
Castello 1, Poli'gono Las Salinas,
08830 Sant Boi de Llobregat Spain
This leaflet was last revised in December 2015
Actavis, Barnstaple, EX32 8NS, UK